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DRKS00017037 | SNCTP000003485

Eine randomisierte, doppelblinde, placebokontrollierte, Studie zum Einfluss von Doxycyclin auf aversives Gedächtnis in Gesunden

Data source: BASEC (Imported from 28.05.2020), WHO (Imported from 22.03.2020)
Changed: 23.04.2020
Disease category: Geistes- und Verhaltenskrankheiten

Brief description of trial (Source of data: BASEC)

Aversives Lernen liegt Erkrankungen wie der spezifischen Phobie oder der posttraumatischen Belastungsstörung zugrunde. In dieser Studie wollen wir untersuchen, ob sich durch das Antibiotikum Doxycyclin das aversive Gedächtnis beeinflussen lässt. Doxycyclin wirkt nach Einnahme kurzfristig auf Eiweisse im Gehirn, die wahrscheinlich auch für die Gedächtnisbildung verantwortlich sind. 560 gesunde Probanden bekommen in dieser Studie entweder eine Dosis von 200 mg Doxycyclin oder eine identisch aussehende unwirksame Substanz (Placebo). Die Zuordnung erfolgt zufällig (randomisiert). Weder Ihnen noch uns ist während der Durchführung der Studie bekannt, ob Sie Doxycyclin oder die unwirksame Substanz erhalten (Doppelverblindung)

Health conditions investigated (Source of data: BASEC)

Wir führen diese Studie durch, um die Gehirnmechanismen kennenzulernen, die das aversive Gedächtnis beim Menschen steuern. Aversives Gedächtnis ist ein Modell für Angsterkrankungen wie z. B. spezifische Phobien.

Health conditions (Source of data: WHO)

healthy subjects

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Wir untersuchen das Antibiotikum Doxyclin, das zur Malariaprophylaxe auch von gesunden Menschen häufig eingenommen wird. Diese Substanz wirkt möglicherweise auf die Aktivität gedächtnisrelevanter Eiweisse im Gehirn ein.

Interventions (Source of data: WHO)

Intervention 1: Vibramycin® Tabs (Doxycyline), 200mg capsule, oral administration, single-dose.

6 experiments will examine whether aversive memories of healthy participants can be influenced by the antibiotic doxycycline. The experiments will be conducted over the time span of several days, however, the medicament will only be taken once, either at the time of memory consolidation or reconsolidation. Intervention 2: Placebo Mannitol PhEur (Perlitol 200SD)
200mg capsule, oral administration, single-dose

Criteria for participation in trial (Source of data: BASEC)

Es können alle gesunden Personen zwischen 18 und 40 Jahren teilnehmen.

Exclusion criteria (Source of data: BASEC)

(1) Aktuelle Erkrankung.
(2) Frühere neurologische, psychiatrische oder systemische Erkrankung
(3) Aktueller oder früherer regelmässiger Gebrauch von abhängig machenden Substanzen (z. B. Alkohol oder Drogen).

Inclusion/Exclusion Criteria (Source of data: WHO)

Inclusion criteria: - Informed Consent as documented by signature
- Age 18 – 40 years
Exclusion criteria: • Allergy to doxycycline or to any other ingredient in the named drugs
• Use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any history of psychiatric, neurological, addiction, or systemic/rheumatic disease
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems
• Participation in another study with investigational drug within 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Members of the study team and their family members and dependants
• Regular work in a medical profession
• Life time history of being a victim of interpersonal violence or other potentially traumatic experience, or close relative of a person with such history

Further information on the trial in WHO primary registry

http://www.drks.de/DRKS00017037

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00017037

Further information on trial

Date trial registered

05.11.2019

Incorporation of the first participant

29.10.2019

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A randomised, double-blind, placebo-controlled study on the impact of doxycycline on aversive memory in healthy individuals - DoxAv

Type of trial (Source of data: WHO)

interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist). Control: Placebo. Assignment: Parallel. Study design purpose: Basic research/physiological study

Phase (Source of data: WHO)

N/A

Primary end point (Source of data: WHO)

Primary endpoints are updated prompt to the start of a new experiment.
Experiment 1:
Fear-potentiated startle, measured via eyeblink EMG of the M. orbicularis oculi and quantified according to Khemka et al. (2017)

Experiment 5:
Quantity and distress of intrusion in an intrusion diary during one week following the trauma film

Secundary end point (Source of data: WHO)

Experiment 1:
SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), pupil reaction, neuropsychological tests (e.g. VLM-T), questionnaires (STAI).

Experiment 5:
Questionnaires (e.g. STAI, BIS-BAS), SCR (skin conductance response), respiration amplitude, heart period measured with ECG (Electrocardiogram), neuropsychological tests (e.g. VLM-T).

Contact information (Source of data: WHO)

Universität Zürich

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Zürich

Countries (Source of data: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Erich Seifritz
+41443842312
erich.seifritz@bli.uzh.ch

Contact for general information (Source of data: WHO)

Janine
Hotz
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 24 58
janine.hotz@bli.uzh.ch

Contact for scientific information (Source of data: WHO)

Dominik
Bach
Lenggstrasse 31
Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich
+41 44 384 24 57
Dominik.bach@uzh.ch

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Department of Psychiatry, Psychotherapy, Psychosomatics, University of Zurich

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2018-01973

Secondary ID (Source of data: WHO)

SNCTP000003485;KEK2018-01973